Recall Z-2857-2026 ยท OWB Interventional Fluoroscopic X-Ray System
Oxos Medical Inc
Brand Name: OXOS Medical, Inc Product Name: MC2 Portable X-Ray System Model/Catalog Number: MC2, MC2.1 Software Version: 5.7.0 Product Description: The MC2 Portable X-Ray System ( MC2 System or MC2 ) is a portable and handheld x-ray system designed to aid clinicians with point of care visualization through diagnostic x-rays of extremities and shoulders. The device allows a clinician to select de
| Date | Aug 3, 2026 (initiated Jun 11, 2026) |
| Status | Open, Classified |
| Reason | Due to a defective circuit board that overheats |
| Root cause | Process change control |
| Action | On 06/12/2026, an "URGENT: Medical Device Recall - Limited to Specific MC2 Units" letter was emailed to customers informing them that, due to faulty circuit boards limited units may experience localized overheating. As a result the firm released a software update (version 5.7.0) which will place a unit in a safe state if boards fail. Customers are instructed to: 1. Update units to software version 5.7.0 via over-air updates. Note, it is important to apply the software update to continue using the MC2 units 2. In addition to the software update, OXOS will replace the defective components wit |
| Quantity | 77 |
| Distribution | US Nationwide distribution in the states of FL, GA, IN, SC, TX, VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K252068 | MC2 Portable X-ray System Oxos Medical, Dec 22, 2025 |